Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02562664

Collaborator

(none)

Enrollment

Arms

5.9

Duration (Months)

Study Details

Study Description

Brief Summary

Polycystic ovary syndrome (PCOS) is the most common Female endocrine disorder , with a prevalence ranging between 6% to10% based on the National Institutes of Health (NIH) criteria and when the broader Rotterdam criteria are applied it reaches as high as 15%. Typically, PCOS can identify during the early adolescence. Insulin resistance is a common finding in the obese women with PCOS. It is most prevalent and severe in PCOS phenotype involving hyperandrogenism and chronic anovulation. Women with PCOS who have regular cycles are metabolically less abnormal. Acanthosis nigricans (AN) is a dermatosis characterized by velvety, papillomatous, brownish-black, hyperkeratotic plaques, typically of the intertriginous surfaces and neck. Although AN is associated with malignancy, the recognition of its more common connection to obesity and insulin resistance allows for diagnosis of related disorders including type 2 diabetes, the metabolic syndrome, and polycystic ovary syndrome. Significant improvements in ovulation and pregnancy rates as a result of clomiphene treatment after metformin in women with clomiphene-resistant PCOS were reported in a popular randomized, double-blind, placebo-controlled trial . The first pharmacological approach to induction of ovulation in women with PCOS is clomiphene citrate

Condition or Disease	Intervention/Treatment	Phase
Reproductive Endocrinology Polycystic Ovarian Syndrome	Drug: CC Drug: Placebo tablets Drug: Metformin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Insulin Sensitizing Agent (Metformin) Improves Clinical Pregnancy Rate and Insulin Parameters in Polycystic Ovarian Syndrome Patients With Acanthosis Nigricans

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CC with placebo 100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with placebo tablets taken twice daily continuously for three cycles.	Drug: CC 100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle Drug: Placebo tablets Placebo tablets taken twice daily continuously for three cycles.
Active Comparator: CC plus Metformin received t100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with plus Metformin 500 mg twice daily continuously for three cycles.	Drug: CC 100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle Drug: Metformin wMetformin (Cidophage , Amon , Egypt) 500 mg twice daily continuously for three cycles.

Arm

Intervention/Treatment

Active Comparator: CC with placebo

100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with placebo tablets taken twice daily continuously for three cycles.

Drug: CC

100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle

Drug: Placebo tablets

Placebo tablets taken twice daily continuously for three cycles.

Active Comparator: CC plus Metformin

received t100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with plus Metformin 500 mg twice daily continuously for three cycles.

Drug: CC

100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle

Drug: Metformin

wMetformin (Cidophage , Amon , Egypt) 500 mg twice daily continuously for three cycles.

Outcome Measures

Primary Outcome Measures

Pregnancy rate [6 months]

Secondary Outcome Measures

Fasting glucose (mg/dl) [6 months]
Fasting insulin (mg/dl) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients with PCOS fulfilled at least 2 out of the three criteria of Rotterdam consensus 2003

Exclusion Criteria:

liver disease
heart or respiratory failure
alcohol abuse
kidney disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammed Khairy Ali, Dr, Assiut University

ClinicalTrials.gov Identifier:

NCT02562664

Other Study ID Numbers:

MPCOS

First Posted:

Sep 29, 2015

Last Update Posted:

Aug 12, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Metformin

Study Results

No Results Posted as of Aug 12, 2020